PolyNovo to file with FDA to seek NovoSorb in US
Calzada (ASX:CZD) subsidiary PolyNovo will seek marketing approval in the US for NovoSorb, its dressing for hard-to-heal pressure sores.
Calzada (ASX:CZD) subsidiary PolyNovo has announced today its intention to file a 510(k) application with the US Food and Drug Administration to secure marketing approval for NovoSorb, its dressing for hard-to-heal pressure sores.
The announcement of the application comes as recruitment for its negative pressure wound therapy (NPWT) trial has been completed, with results expected in April.
The trial is intended to demonstrate that safety and efficacy of the treatment is at least as good as the existing market leader in NPWT, namely Granufoam from Kinetic Concepts.
In August last year the company announced that it expected delays in the completion of another trial involving NovoSorb, this time treating burns.
Calzada (ASX:CZD) was up half a cent in morning trading to 5c on the back of the news.
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